Saturday, January 15, 2011

Now, in response to information obtained by Nature under the US Freedom of Information Act, Kornbluth and Cuffe have offered their account of the mistakes that led the trials to be restarted even after they learned of potential flaws in the underlying data. The affair will have an impact beyond Duke, as the Institute of Medicine, part of the US National Academies in Washington DC, begins to examine research on genome-based patient testing. Originally commissioned to investigate Duke's controversial trials, the institute's US$687,000 study is now expected to focus on providing broader recommendations for the design of clinical trials that similarly use genomic data from individual patients to tailor therapy.